Alpelisib
Alpelisib (Piqray, Novartis Europharm Limited) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: PIK3CA (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer1 | |||
PIK3CA mutation, HR-positive, HER2-negative | + fulvestrant | 2L advanced | Following an endocrine-based regimen; Postmenopausal women, and men |
Full text of section 4.1 (therapeutic indications)
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).
Label history
18 changes to the Piqray label since 2021, 1 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes